With Donald Trump returning to the Oval Office following his 2024 presidential victory, many Americans are revisiting his prior policies, including those aimed at healthcare access and deregulation. One prominent achievement Trump frequently cites is the 2018 “Right to Try” law.
Designed to streamline the process for terminally ill patients to access experimental medications outside the FDA’s established approval channels, the Right to Try Act has been a point of both praise and controversy. For rehabilitation centers and healthcare providers nationwide, this legislation raises significant questions about patient safety and the broader implications of deregulating drug access.
The Origins and Goals of Right to Try
Signed into law in 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act was framed as a compassionate measure to allow terminally ill patients access to potentially lifesaving treatments still in experimental phases. Trump has heralded this law as a breakthrough, claiming it has “saved thousands and thousands of lives.” However, many medical experts, ethicists, and advocates have noted that Right to Try has fallen short of such claims.
Right to Try was created as an alternative to the FDA’s Expanded Access Program, sometimes known as “compassionate use.” This FDA program, established in the 1970s and legally codified in 1987, already provided a pathway for terminally ill patients to seek experimental drugs. While Right to Try aimed to accelerate access by bypassing the FDA’s review process, critics argue it sacrifices necessary safety protocols and provides limited additional benefits for patients.
Key Differences Between Right to Try and Expanded Access
The Right to Try Act allows patients with life-threatening illnesses to seek medications that have passed only the initial Phase 1 clinical trials, which primarily test for safety in small groups.
By contrast, the FDA’s Expanded Access Program has a more flexible approach, permitting access to medications still in early trial phases as long as certain safety protocols are in place. Under Expanded Access, the FDA and an institutional review board (IRB) review each request, working alongside the patient’s doctor and the drug manufacturer to weigh potential benefits against risks.
Under Right to Try, the FDA is effectively removed from the process, leaving approval to the discretion of the drug’s manufacturer. While proponents of Right to Try argue that this minimizes bureaucratic hurdles, detractors worry that it eliminates safeguards designed to protect vulnerable patients from untested and potentially harmful treatments.
Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania’s Perelman School of Medicine, has cautioned that Right to Try may “open up the opportunity of exploiting desperate patients” who are willing to try anything in the face of a terminal diagnosis.
Right to Try’s Impact and the Reality Behind Trump’s Claims
Despite Trump’s claims that Right to Try has saved “thousands and thousands of lives,” government data does not substantiate such large-scale impact. In fact, data from the FDA indicates that since the program’s inception, only 16 medications have been authorized under Right to Try. This figure suggests that while the program may have benefited some patients, it has not achieved the widespread effect Trump describes.
Experts say that financial limitations—rather than regulatory ones—are often the primary challenge for patients, as experimental treatments are frequently costly and insurance coverage is limited or non-existent.
Medical professionals, like Alison Bateman-House, a researcher specializing in access to investigational medical products at NYU’s Grossman School of Medicine, suggest that Right to Try may even narrow options for patients by limiting the range of drugs available.
Right to Try, for instance, applies only to patients with a “life-threatening” condition, as opposed to the FDA’s more inclusive criterion of “serious or life-threatening” conditions. Consequently, fewer patients qualify under Right to Try than under the FDA’s Expanded Access Program.
Patient Safety Concerns and Informed Consent
One of the key concerns surrounding Right to Try is the relaxation of informed consent requirements. While the FDA’s Expanded Access Program mandates clear disclosure of experimental treatments’ risks, Right to Try lacks explicit guidelines on informed consent, potentially leaving patients less informed about possible side effects and adverse outcomes.
Additionally, Right to Try prevents the FDA from using adverse outcomes to delay or halt a drug’s approval process unless there is a public health justification. For some healthcare providers, this provision raises ethical concerns about prioritizing deregulation over patient safety.
The lack of transparency around Right to Try’s impact also limits public understanding. The FDA does not track the number of patients treated or the outcomes associated with Right to Try cases, meaning that there is little accountability or data to validate Trump’s claims about the program’s success.
Fernandez Lynch, the bioethicist from the University of Pennsylvania, has noted that these “very, very low” patient numbers contradict the narrative that Right to Try is widely used or significantly beneficial.
Right to Try and Its Implications for Rehabilitation Centers
For rehabilitation centers in Indiana like Sunrise Recovery, the Right to Try Act is a reminder of the importance of balancing innovation with safety. While new therapies can offer hope, especially for those with severe or life-threatening conditions, they also come with risks.
Our center is dedicated to providing treatments that are not only effective but also safe, ensuring that patients and their families have access to reliable, well-vetted options. Experimental treatments can be valuable, but they must be accompanied by appropriate safeguards to protect patients from unnecessary harm.
Trump’s return to the presidency may bring renewed efforts to expand Right to Try or similar programs aimed at deregulating healthcare. Advocacy groups, like the conservative Goldwater Institute, are already calling for a “Right to Try 2.0,” which would potentially expand access to personalized medicine.
However, experts caution that existing programs, like the FDA’s Expanded Access Program, already provide pathways for patients to seek innovative treatments, balancing access with oversight.
Looking Ahead: Patient-Centered Care and Ethical Responsibility
As we navigate a healthcare landscape shaped by policies like Right to Try, it is essential to advocate for programs that prioritize patient safety and informed consent. While expanded access to experimental drugs is a worthy goal, it should not come at the expense of rigorous safety protocols and ethical transparency. Right to Try’s implementation over the past six years has highlighted both the potential and the challenges of deregulating access to experimental treatments.
For our patients and their families, we remain committed to providing compassionate, evidence-based care. We recognize the allure of new therapies, especially in situations where conventional treatments have been exhausted. However, we believe in supporting policies that balance hope with caution, ensuring that every patient receives treatments that have undergone thorough review to confirm both safety and efficacy.
In an era of rapid medical innovation, the goal of expanding treatment options is a shared priority. By maintaining ethical standards and prioritizing patient well-being, we can work toward a healthcare system that is not only innovative but also trustworthy.
At Sunrise Recovery, we prioritize informed, compassionate care and uphold a commitment to safe, evidence-based treatments for all patients. While new policies may emerge to shape how experimental treatments are accessed, we remain focused on advocating for programs that balance innovation with patient safety.
